Pharvaris Announces FDA Clinical Hold on PHA121 Clinical Trials in the U.S.
August 22 2022 - 6:50AM
Pharvaris (Nasdaq: PHVS), a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
hereditary angioedema (HAE) attacks, today announced that the U.S.
Food and Drug Administration (FDA) verbally informed Pharvaris
that, based on its review of nonclinical data, the agency is
placing a clinical hold on the clinical trials of PHA121 in the
U.S. under two Pharvaris Investigational New Drug (IND)
applications for the treatment of HAE. The FDA indicated it will
provide a formal clinical hold letter to Pharvaris in approximately
30 days. The company plans to provide additional updates following
interactions with the FDA.
“We are fully committed to working closely with the FDA to
address the agency’s concerns,” said Berndt Modig, chief executive
officer of Pharvaris. “Pharvaris remains dedicated to providing new
therapeutic choices for the treatment of HAE and is working
diligently to bring PHA121 to people living with HAE.”
About PharvarisPharvaris is a clinical-stage
company developing novel, oral bradykinin-B2-receptor antagonists
to treat and prevent HAE attacks, building on its deep-seated roots
in HAE. By directly targeting this clinically proven therapeutic
target with novel small molecules, the Pharvaris team aspires to
offer people with all sub-types of HAE effective and convenient
alternatives to treat attacks, both on-demand and prophylactically.
The company brings together the best talent in the industry with
deep expertise in rare diseases and HAE. For more information,
visit https://pharvaris.com/.
Forward-Looking StatementsThis press release
contains certain forward-looking statements that involve
substantial risks and uncertainties. All statements contained in
this press release that do not relate to matters of historical fact
should be considered forward-looking statements, including, without
limitation, statements containing the words “believe,”
“anticipate,” “expect,” “estimate,” “may,” “could,” “should,”
“would,” “will,” “intend” and similar expressions. These
forward-looking statements are based on management’s current
expectations, are neither promises nor guarantees, and involve
known and unknown risks, uncertainties and other important factors
that may cause Pharvaris’ actual results, performance or
achievements to be materially different from its expectations
expressed or implied by the forward-looking statements. Such risks
include but are not limited to the following: uncertainty in the
outcome of our interactions with regulatory authorities, including
the FDA’s clinical hold on PHA121 clinical trials in the U.S.; the
expected timing, progress, or success of our clinical development
programs, especially for PHVS416 and PHVS719, which were in
mid-stage clinical trials and are currently on hold as a result of
the clinical hold; risks associated with the COVID-19 pandemic,
which may adversely impact our business, nonclinical studies, and
clinical trials; the timing of regulatory approvals; the value of
our ordinary shares; the timing, costs and other limitations
involved in obtaining regulatory approval for our product
candidates PHVS416 and PHVS719, or any other product candidate that
we may develop in the future; our ability to establish commercial
capabilities or enter into agreements with third parties to market,
sell, and distribute our product candidates; our ability to compete
in the pharmaceutical industry and with competitive generic
products; our ability to market, commercialize and achieve market
acceptance for our product candidates; our ability to raise capital
when needed and on acceptable terms; regulatory developments in the
United States, the European Union and other jurisdictions; our
ability to protect our intellectual property and know-how and
operate our business without infringing the intellectual property
rights or regulatory exclusivity of others; our ability to manage
negative consequences from changes in applicable laws and
regulations, including tax laws, our ability to successfully
remediate the material weakness in our internal control over
financial reporting and to maintain an effective system of internal
control over financial reporting; changes in general market,
political and economic conditions, including as a result of the
current conflict between Russia and Ukraine; and the other factors
described under the headings “Cautionary Statement Regarding
Forward-Looking Statements” and “Item 3. Key Information—D. Risk
Factors” in our Annual Report on Form 20-F and other periodic
filings with the Securities and Exchange Commission.
These and other important factors could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management’s estimates as of the date of this
press release. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. While Pharvaris may elect to update such
forward-looking statements at some point in the future, Pharvaris
disclaims any obligation to do so, even if subsequent events cause
its views to change. These forward-looking statements should not be
relied upon as representing Pharvaris’ views as of any date
subsequent to the date of this press release.
ContactsPharvarisMaryann
CiminoDirector of Corporate
Relations+1-617-710-7305maryann.cimino@pharvaris.com
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